Trial to Assess the Effects of Vorapaxar (SCH 530348; MK-5348) in Preventing Heart Attack and Stroke in Patients With Atherosclerosis (TRA 2°P - TIMI 50) (P04737)

Last updated: August 22, 2018
Sponsor: Merck Sharp & Dohme Corp.
Overall Status: Completed

Phase

3

Condition

Atherosclerosis

Claudication

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT00526474
P04737
2006-002942-12
TRA 2°P - TIMI 50
MK-5348-015
  • Ages > 18
  • All Genders

Study Summary

The study is designed to determine whether vorapaxar, when added to the existing standard of care (SOC) for preventing heart attack and stroke (eg, aspirin, clopidogrel) in participants with a known history of atherosclerosis, will yield additional benefit over the existing standard of care without vorapaxar in preventing heart attack and stroke.

The study is also designed to assess risk of bleeding with vorapaxar added to the standard of care versus the standard of care alone.

Eligibility Criteria

Inclusion

Inclusion Criteria: Men and women at least 18 years old with evidence or a history of atherosclerosis involvingthe coronary, cerebral, or peripheral vascular systems by one or more of the following:

  • history of myocardial infarction (heart attack)

  • history of ischemic stroke (stroke due to a blocked artery)

  • history of peripheral arterial disease

Exclusion

Exclusion Criteria:

  • history of intracranial hemorrhage or of central nervous system (CNS) surgery, tumor,or aneurysm

  • any bleeding disorder or abnormality

  • sustained severe hypertension or valvular heart disease

  • current or recent platelet count <100,000 mm^3

  • planned or ongoing treatment with a blood thinning medication

  • pregnancy

  • any significant medical or physiological condition or abnormality that could put thesubject at increased risk or limit the subject's ability to participate for theduration of the study

Study Design

Total Participants: 26449
Study Start date:
September 01, 2007
Estimated Completion Date:
December 01, 2011